Conectar
Chronic venous leg ulcers (CVLUs) affect 1%–3% of adults. Standard compression therapy achieves healing in only 40%–70% of cases at 24 weeks. Evidence for hyperbaric oxygen (HBO) therapy remains controversial, with limited sham-controlled trials. To evaluate whether adjunctive HBO improves healing of refractory CVLUs compared to standard care alone. Single-centre, open-label randomised trial of 80 adults with CVLUs that persisted > 3 months despite standard care (defined as < 30% area reduction after 4 weeks of compression therapy). All consecutive eligible patients were randomised to HBO (20 sessions at 2.4 ATA, 90 min) plus standard care (n = 40) or standard care alone (n = 40). Primary outcome: percentage ulcer area reduction at day 30. Blinded assessors measured wounds, though participants knew their treatment allocation. HBO group had greater area reduction (62.1% ± 22.1% vs. 41.7% ± 21.5%; mean difference 20.4%, 95% CI: 10.1–30.7, p < 0.001; Cohen's d = 0.95). Complete healing at 90 days occurred in 62.5% vs. 30.0% (NNT = 3). TcPO2 increased from 26.1 ± 6.3 to 150.3 ± 45.6 mmHg in HBO group (p < 0.001). Pain decreased more with HBO (ΔVAS −5.0 vs. −1.5, p < 0.001). Three patients (7.5%) had mild ear barotrauma that resolved spontaneously. Main limitations were lack of sham control and 90-day follow-up. In this trial, adjunctive HBO was associated with faster short-term healing of refractory venous ulcers < 20 cm2. However, the open-label design and single-centre setting limit confidence in these findings. Sham-controlled multicentre trials with longer follow-up are needed before recommending routine use.
Secondary and tertiary renal hyperparathyroidism (RHPT) are common sequelae of chronic kidney disease and are associated with worse patient mortality and quality of life. Clinical guidelines remain lacking with regard to recommendations for using intraoperative parathyroid hormone (IOPTH) during surgery for RHPT. A prospective randomised study will help evaluate the role of IOPTH in guiding surgery for secondary and tertiary RHPT.
Intraoperative parathyroid hormone monitoring to guide surgery in renal hyperparathyroidism is a pragmatic, multicentre, five-arm, parallel-group, patient-blinded and outcome assessor-blinded prospective pilot trial used to evaluate the feasibility of performing a definitive trial. Eligible participants include adult patients diagnosed with secondary or tertiary hyperparathyroidism who are candidates for subtotal or total parathyroidectomy. Consenting patients will be randomly assigned, through central allocation, in a 1:1:1:1:1 fashion to undergo surgery with IOPTH monitoring (four experimental arms: postexcision IOPTH samples taken at 10, 15, 20 or 25 min) or to undergo surgery without IOPTH monitoring (control arm). The primary feasibility objective is to estimate the percentage of eligible patients that are randomised: ≥70% proceed; 50–69% modify protocol before proceeding;
Ethics approval was obtained from the Hamilton Integrated Research Ethics Board. Pilot trial results will be shared widely through local, national and international academic and clinical networks and will be disseminated through conference presentations and publication in peer-reviewed journals.
NCT06542315, registered on 6 August 2024.
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